CQV — Commissioning, Qualification, and Validation — is the framework pharma uses to ensure that facilities, equipment, and processes consistently produce safe, compliant products. The three phases are distinct: each has a different owner, a different regulatory basis, and a different definition of success. Confusing them is one of the most common reasons CQV projects stall during inspections.
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The Three Phases Explained
Is it installed and working?
An engineering activity verifying that equipment and systems are installed per design specifications and operating correctly. Covers Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). Not a GxP regulatory requirement — but well-documented commissioning data meeting ALCOA+ standards can be leveraged as qualification evidence.
Does it meet specification?
A regulated GxP activity verifying that equipment and systems meet their predetermined specifications and are suitable for intended use. Executed through IQ, OQ, and PQ protocols with documented evidence. Subject to FDA and EMA oversight. Results must meet defined acceptance criteria.
Does it consistently produce quality?
Documented evidence that a process — manufacturing, cleaning, analytical, or computerised system — consistently produces outputs meeting predetermined quality and regulatory requirements. Validation is broader than qualification and includes process validation, cleaning validation, and computer system validation (CSV).
IQ, OQ, PQ: The Qualification Lifecycle
Qualification progresses through three documented stages — each building on the previous and required before advancing to the next.
| Stage | Core Question | What It Verifies | Typical Evidence | |
|---|---|---|---|---|
| IQ | Installation Qualification | Was it installed correctly? | Equipment installed per design specifications, manufacturer requirements, and applicable standards | Component checklists, calibration records, P&ID verification, utility connections |
| OQ | Operational Qualification | Does it operate as specified? | Equipment operates within specified ranges and functional parameters under normal and worst-case conditions | Functional test results, alarm testing, alarm limits verification, operating range confirmation |
| PQ | Performance Qualification | Does it perform consistently? | Equipment consistently produces results meeting user requirements under real production conditions | Process runs, product quality data, statistical analysis, operator procedure confirmation |
IQ/OQ/PQ are not optional checkboxes — they are the evidence base that regulators evaluate when assessing whether a facility can reliably produce safe pharmaceutical products. Missing or incomplete phases are a common source of FDA 483 observations and Warning Letters.
Regulatory Framework
Requires documented qualification of equipment and computerised systems used in drug manufacturing. IQ/OQ/PQ evidence must be on file and available for inspection.
Governs qualification and validation in EU pharmaceutical manufacturing — covers DQ, IQ, OQ, PQ, process validation, and change control requirements.
ASTM E2500 provides the standard guide for pharma manufacturing system qualification. ICH Q9 provides the risk management framework for scaling qualification effort to system risk.
GoVal and CQV
GoVal manages DQ, IQ, OQ, and PQ protocols in one pre-validated platform — with live RTM, Part 11-compliant e-signatures, in-platform deviation logging, and automatic Qualification Summary Report generation. Qualification scope scales to system risk via the GAMP 5 engine.
Frequently Asked Questions
What is CQV in pharma? +
What is the difference between commissioning and qualification in pharma? +
What are IQ OQ PQ in pharma qualification? +
What regulations govern CQV in pharma? +
How does GoVal support commissioning, qualification, and validation? +
Manage your full CQV lifecycle in one platform
GoVal handles DQ, IQ, OQ, PQ, live RTM, and automatic qualification reports — pre-validated and live in 3–6 weeks.